Trial Outcomes & Findings for Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis (NCT NCT00613171)
NCT ID: NCT00613171
Last Updated: 2021-07-07
Results Overview
The efficacy of oral STI571 in participants with systemic sclerosis is defined by an improvement in MRSS. Skin thickness was assessed clinically in each of 17 body areas and scored using a 0-3 scale, where 0= normal, 1= mild thickness, 2= moderate thickness, and 3= severe thickness (maximum score 51). A higher score indicates greater severity of the disease.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
27 participants
Primary outcome timeframe
Baseline, Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48/End of Study (EOS)
Results posted on
2021-07-07
Participant Flow
This study was conducted at 7 centers in 5 countries from 02 January 2008 to 13 January 2010.
The study enrolled a total of 27 participants. The study consisted of a treatment period of 24 weeks and a follow-up period of 24 weeks with no study drug.
Participant milestones
| Measure |
STI571
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
13
|
|
Overall Study
NOT COMPLETED
|
14
|
Reasons for withdrawal
| Measure |
STI571
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Overall Study
Adverse Event
|
7
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Reason not Specified
|
4
|
Baseline Characteristics
Efficacy and Tolerability of STI571 (Imatinib Mesylate) for the Treatment of Fibrosis in Participants With Systemic Sclerosis
Baseline characteristics by cohort
| Measure |
STI571
n=27 Participants
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Age, Continuous
|
45.7 years
STANDARD_DEVIATION 11.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48/End of Study (EOS)Population: Efficacy analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement. Number analyzed are the number of participants with data available for analyses at given time point.
The efficacy of oral STI571 in participants with systemic sclerosis is defined by an improvement in MRSS. Skin thickness was assessed clinically in each of 17 body areas and scored using a 0-3 scale, where 0= normal, 1= mild thickness, 2= moderate thickness, and 3= severe thickness (maximum score 51). A higher score indicates greater severity of the disease.
Outcome measures
| Measure |
STI571
n=27 Participants
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Baseline
|
25.7 units on a scale
Standard Deviation 5.83
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 2
|
6.58 units on a scale
Standard Deviation 18.416
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 4
|
5.97 units on a scale
Standard Deviation 17.382
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 6
|
8.34 units on a scale
Standard Deviation 24.645
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 8
|
8.48 units on a scale
Standard Deviation 27.096
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 12
|
3.34 units on a scale
Standard Deviation 27.525
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 16
|
12.70 units on a scale
Standard Deviation 28.399
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 20
|
12.41 units on a scale
Standard Deviation 28.149
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 24
|
9.90 units on a scale
Standard Deviation 23.675
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 28
|
-3.17 units on a scale
Standard Deviation 19.891
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 32
|
-5.67 units on a scale
Standard Deviation 18.013
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 36
|
-12.61 units on a scale
Standard Deviation 27.383
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 40
|
-5.23 units on a scale
Standard Deviation 27.506
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 44
|
-13.57 units on a scale
Standard Deviation 26.763
|
|
Change From Baseline in Modified Rodnan Skin Score (MRSS) at Each Time Point of Analysis
Week 48/ EOS
|
-20.89 units on a scale
Standard Deviation 24.946
|
PRIMARY outcome
Timeframe: Baseline to Week 48/EOSPopulation: Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
An AE is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to the study drug. An SAE is defined as an event that is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, is medically significant, i.e., defined as an event that jeopardizes the patient or may require medical or surgical intervention to prevent one of the outcomes listed above.
Outcome measures
| Measure |
STI571
n=27 Participants
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Number of Participants With Adverse Events (AE's) and Serious Adverse Events (SAE's)
Participants Experiencing AE's
|
27 Participants
|
|
Number of Participants With Adverse Events (AE's) and Serious Adverse Events (SAE's)
Participants Experiencing SAE's
|
5 Participants
|
SECONDARY outcome
Timeframe: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and Week 48/End of Study (EOS)Population: Efficacy analysis set included all participants that received at least one dose of the study drug with at least one post-baseline measurement. Number analyzed are the number of participants with data available for analyses at given time points.
The following MRSS categories were calculated for up to Week 48: Non-response: a reduction in MRSS \<25%, Partial response: a reduction in MRSS between 25-\<50%, Complete response: a reduction in MRSS between 50-\<80%, Remission: a reduction in MRSS ≥80%.
Outcome measures
| Measure |
STI571
n=27 Participants
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 2 · Non-response
|
27 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 2 · Partial Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 2 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 2 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 4 · Non-response
|
25 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 4 · Partial Response
|
2 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 4 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 4 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 6 · Non-response
|
24 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 6 · Partial Response
|
2 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 6 · Complete Response
|
1 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 6 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 8 · Non-response
|
22 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 8 · Partial Response
|
2 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 8 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 8 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 12 · Non-response
|
15 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 12 · Partial Response
|
3 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 12 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 12 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 16 · Non-response
|
16 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 16 · Partial Response
|
2 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 16 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 16 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 20 · Non-response
|
16 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 20 · Partial Response
|
2 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 20 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 20 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 24 · Non-response
|
15 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 24 · Partial Response
|
1 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 24 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 24 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 28 · Non-response
|
13 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 28 · Partial Response
|
1 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 28 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 28 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 32 · Non-response
|
13 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 32 · Partial Response
|
1 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 32 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 32 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 36 · Non-response
|
9 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 36 · Partial Response
|
3 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 36 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 36 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 40 · Non-response
|
9 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 40 · Partial Response
|
3 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 40 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 40 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 44 · Non-response
|
8 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 44 · Partial Response
|
5 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 44 · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 44 · Remission
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 48/EOS · Non-response
|
5 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 48/EOS · Partial Response
|
8 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 48/EOS · Complete Response
|
0 Participants
|
|
Number of Participants With Non-response, Partial Response, Complete Response, and Remission Assessed by MRSS Values
Week 48/EOS · Remission
|
0 Participants
|
Adverse Events
ST1571
Serious events: 5 serious events
Other events: 27 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
ST1571
n=27 participants at risk
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Blood and lymphatic system disorders
Neutropenia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Gastritis erosive
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Nausea
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Vomiting
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Face oedema
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Generalised oedema
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Oedema peripheral
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Neutropenic infection
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Viral infection
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Haematocrit decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
Other adverse events
| Measure |
ST1571
n=27 participants at risk
Participants received ST1571 100 mg tablets, orally, once daily. Initiated at an oral dose of 200 mg/day for 4 weeks then titrated up to 400 mg/day for 2 weeks followed by 600 mg/day until Week 24, if well tolerated.
|
|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
22.2%
6/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Blood and lymphatic system disorders
Leukopenia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Blood and lymphatic system disorders
Lymphopenia
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Blood and lymphatic system disorders
Thrombocytosis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Cardiac disorders
Cardiac disorder
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Ear and labyrinth disorders
Auricular swelling
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Ear and labyrinth disorders
Ear pain
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Ear and labyrinth disorders
Tinnitus
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Eye disorders
Eye swelling
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Eye disorders
Eyelid oedema
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Eye disorders
Ocular hyperaemia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Abdominal distension
|
14.8%
4/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Constipation
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.9%
7/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Diverticulum
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Dry mouth
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Dyspepsia
|
14.8%
4/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Faeces discoloured
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Flatulence
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Gingival pain
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Nausea
|
51.9%
14/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Tongue dry
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Toothache
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Gastrointestinal disorders
Vomiting
|
18.5%
5/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Face oedema
|
18.5%
5/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Fatigue
|
18.5%
5/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Generalised oedema
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Influenza like illness
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Infusion site ulcer
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Oedema
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Oedema peripheral
|
55.6%
15/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Herpes zoster
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Infected skin ulcer
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Influenza
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Infusion site infection
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Lower respiratory tract infection
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Nasopharyngitis
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Oral fungal infection
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Oral herpes
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Pharyngitis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Respiratory tract infection
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Rhinitis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Sinusitis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Tonsillitis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Upper respiratory tract infection
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Urinary tract infection
|
14.8%
4/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Viral infection
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Infections and infestations
Vulvovaginal candidiasis
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Injury, poisoning and procedural complications
Back injury
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Injury, poisoning and procedural complications
Joint injury
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Injury, poisoning and procedural complications
Procedural site reaction
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Alanine aminotransferase increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Aspartate aminotransferase increased
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood albumin decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood alkaline phosphatase increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood amylase increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood cholesterol increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood creatine phosphokinase increased
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood triglycerides increased
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood urea increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Blood uric acid decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
C-reactive protein increased
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Electrocardiogram QRS complex abnormal
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Electrocardiogram abnormal
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Gamma-glutamyltransferase increased
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Haematocrit decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Haemoglobin decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Heart rate irregular
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
High density lipoprotein decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Laboratory test interference
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Lipase increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Neutrophil count decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Platelet count increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Protein total abnormal
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Red blood cell count decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Red blood cell sedimentation rate increased
|
14.8%
4/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Troponin I increased
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Weight decreased
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
Weight increased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Investigations
White blood cell count decreased
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.9%
7/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Joint range of motion decreased
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Sensation of heaviness
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Systemic sclerosis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis stenosans
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Nervous system disorders
Dizziness
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Nervous system disorders
Dysgeusia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Nervous system disorders
Headache
|
18.5%
5/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Nervous system disorders
Neuralgia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Nervous system disorders
Paraesthesia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Psychiatric disorders
Depression
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Psychiatric disorders
Insomnia
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Psychiatric disorders
Sleep disorder
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Reproductive system and breast disorders
Menorrhagia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.4%
2/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Lentigo
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Panniculitis
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Periorbital oedema
|
18.5%
5/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
33.3%
9/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Skin tightness
|
11.1%
3/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
18.5%
5/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Vascular disorders
Erythromelalgia
|
3.7%
1/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
|
Vascular disorders
Raynaud's phenomenon
|
14.8%
4/27 • Baseline to Week 48/EOS
Safety analysis set included all participants who received at least one dose of the study drug with at least one post-baseline measurement.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER